H5N1 Vaccination With and Without AS03: Systems Biology Analysis

Summary

This is a single center, randomized, double-blinded, controlled, Phase I, small targeted prospective study in healthy male and non-pregnant female subjects, 18 to 49 years old, inclusive, designed to determine the safety, reactogenicity, and immunogenicity of an intramuscular subvirion inactivated monovalent influenza A/H5N1 (HA of A/Indonesia/05/2005) virus vaccine manufactured by Sanofi Pasteur administered at 3.75 mcg per dose given with or without AS03 adjuvant manufactured by GSK. In the study, each subject will receive two doses administered 28 days apart. This study will use a systems biology approach to assess the human early gene and protein signatures expressed at Days 1, 3, 7, and 28 after the first vaccination. The systems data will be integrated with immunogenicity and reactogenicity data to develop a systems model of the human immune response to A/H5N1 vaccine with or without AS03 adjuvant.

Timeline

Start

2012-05-24

Primary completion

2014-01-02

Completion

2014-01-02

Publications

• Howard LM, Jensen TL, Goll JB, Gelber CE, Bradley MD, Sherrod SD, Hoek KL, Yoder S, Jimenez-Truque N, Edwards K, Creech CB. Metabolomic Signatures Differentiate Immune Responses in Avian Influenza Vaccine Recipients. J Infect Dis. 2024 Sep 23;230(3):716-725. doi: 10.1093/infdis/jiad611.
• Howard LM, Hoek KL, Goll JB, Samir P, Galassie A, Allos TM, Niu X, Gordy LE, Creech CB, Prasad N, Jensen TL, Hill H, Levy SE, Joyce S, Link AJ, Edwards KM. Cell-Based Systems Biology Analysis of Human AS03-Adjuvanted H5N1 Avian Influenza Vaccine Responses: A Phase I Randomized Controlled Trial. PLoS One. 2017 Jan 18;12(1):e0167488. doi: 10.1371/journal.pone.0167488. eCollection 2017.

Drugs

Indications